drugset / Trial / NCT07439549
Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Phase 4
Recruiting
12 enrolled
Pouya Azar
British Columbia Centre for Excellence in HIV/AIDS · collabVGH and UBC Hospital Foundation · collabVancouver General Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical study is to evaluate a new treatment approach called symptom inhibited naloxone induction (SINI) for people with opioid use disorder. In this study, participants will receive small doses of intravenous (IV) naloxone at intervals until they feel mild opioid withdrawal symptoms. At this point, they will be given buprenorphine/naloxone under the tongue to help with the withdrawal symptoms. One hour after, they will receive a injection of long acting buprenorphine under the skin if they choose to. The main questions this study aims to answer are: Is it feasible to use the SINI protocol in inpatient and outpatient settings? Is the SINI protocol safe and tolerable for individuals with opioid use disorder?
Timeline
- Start
- 2026-04-29
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 300 mg | Subcutaneous |
| Subject | Buprenorphine/naloxone | Unknown | 2 mg | Other |
| Subject | Buprenorphine/naloxone | Unknown | 8 mg | Other |
| Background | Naloxone | Small molecule | 0.1 mg | Intravenous |
| Background | Naloxone | Small molecule | 0.2 mg | Intravenous |